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ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04460677
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Vanessa H. Bal, PhD, Rutgers, The State University of New Jersey

Brief Summary:
The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a brief, telehealth intervention (the Emotional Support Plan), intended to support autistic adults to cope with their negative emotions during and/or after the COVID-19 pandemic. The first objective is to develop and refine a brief telehealth-delivered treatment, the Emotional Support Plan (ESP), to help promote adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic. The second objective is to assess the feasibility and effectiveness of the ESP to support autistic adults to implement emotion regulation strategies during periods of acute distress. The last objective is to yield preliminary data to apply for extramural grants to validate these methods to monitor and support mental health of autistic adults during key transitions (e.g., starting college).

Condition or disease Intervention/treatment Phase
Psychological Distress Stress, Psychological Autism Spectrum Disorder Behavioral: Emotional Support Plan Behavioral: Daily Monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19 (Coronavirus Disease)
Actual Study Start Date : August 12, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Emotional Support Plan (ESP) + Weekly Monitoring
This will involve weekly assessments without prompting to use the plan.
Behavioral: Emotional Support Plan
The Emotional Support Plan (ESP) is designed to help adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic.

Experimental: Emotional Support Plan (ESP) + 4x Daily Monitoring
Participants in this arm will be prompted on their phones 4x/day randomly, to report on activities, mood, suicidal ideation, distress level and ESP use since the last prompt
Behavioral: Emotional Support Plan
The Emotional Support Plan (ESP) is designed to help adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic.

Behavioral: Daily Monitoring
The daily monitoring will remind participants 4x/day to report on their mood, distress, etc. and use their ESP if needed.




Primary Outcome Measures :
  1. Decreased distress on Patient Health Questionnaire (PHQ-9) [ Time Frame: 8 week study period ]
    The PHQ-9, assessed weekly, is a 9-item questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more distress.

  2. Decreased distress on EMA reports [ Time Frame: 8 week study period ]
    EMA (Ecological Momentary Assessment) reports of decreased distress (in ESP + daily monitoring group only). Higher scores on the item equal higher levels of distress.

  3. Decreased anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7) [ Time Frame: 8 week study period ]
    The GAD-7, assessed weekly, is a 7-item questionnaire of anxiety symptoms over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more anxiety.


Secondary Outcome Measures :
  1. Adult Self Report (ASR) [ Time Frame: 8 week study period ]
    The ASR is a measure of adaptive functioning and psychopathology (e.g., anxiety, depression symptoms). Most of the items are on a 3 point scale including: (0) Not true, (1) Somewhat or sometimes true, and (2) Very often or often true.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria Adults 18 years or older with previously established diagnoses in ASD will be invited to participate. Adults who have a verbal IQ above 70 or who are students admitted to a college or university will be included in the study.

Exclusion Criteria

  • Individuals who are younger than 18 years old or who does not have diagnosis of ASD will excluded from the study as the purpose of the current research is to evaluate the validity of ESPs in adults with autism.
  • Adults who are unable to understand English will be excluded because the instruments being investigated are currently only validated in English and the study team is not sufficiently fluent in other languages to provide assurance that informed consent could be obtained (or intervention provided) in a language besides English.
  • Subjects without access to a compatible iOS and Android smartphone (nearly all phones from the past 10 years are compatible) will be excluded because the study requires subjects to record responses on a smartphone app. Individuals will not be excluded from the study based on race, ethnicity or gender.
  • Subjects who have a verbal IQ below 70 will be excluded as this is a study that requires self-report and engagement in a one-on-one intervention.
  • If the PI's clinical judgment is that it would not be in the adult's best interest to be enrolled, they may also be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460677


Locations
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United States, New Jersey
Rutgers University Recruiting
Piscataway, New Jersey, United States, 08854
Contact: Vanessa H Bal    848-445-9384    lifespanlab@rutgers.edu   
Principal Investigator: Vanessa H Bal, Ph.D.         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
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Responsible Party: Vanessa H. Bal, PhD, Assistant Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT04460677    
Other Study ID Numbers: Pro2020001593
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Plan will be decided as study progresses.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vanessa H. Bal, PhD, Rutgers, The State University of New Jersey:
smartphone
ecological momentary intervention (EMI)
ecological momentary assessment (EMA)
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Stress, Psychological
Neurodevelopmental Disorders
Mental Disorders
Behavioral Symptoms